Cetuximab and Carboplatin in Treating Patients With Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Phase 2

Completed

• Conditions: Ovarian Cancer; Primary Peritoneal Cavity Cancer

• Registration Number: NCT00086892
• Lead Sponsor: Gynecologic Oncology Group

Brief Summary

RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy such as carboplatin work in different ways to stop tumor cells from dividing so they stop growing or die. Combining cetuximab with carboplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with carboplatin works in treating patients with recurrent ovarian epithelial cancer or primary peritoneal cancer.

Detailed Description

OBJECTIVES:

* Determine the antitumor activity of cetuximab and carboplatin in patients with recurrent platinum-sensitive ovarian epithelial or primary peritoneal cancer.

* Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days 1, 8 , and 15. Patients also receive carboplatin IV after cetuximab administration on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 20-65 patients will be accrued for this study.

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2004-07-08
• Study First Submitted QC: 2004-07-09
• Study First Posted: 2004-07-12
• Primary Completion: 2006-04
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-12
• Last Update Posted: 2014-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (75)

Comprehensive Cancer Center at University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

CCOP - Western Regional, Arizona; 🇺🇸 Phoenix, Arizona, United States

Jonsson Comprehensive Cancer Center at UCLA; 🇺🇸 Los Angeles, California, United States

Women's Cancer Center - Los Gatos; 🇺🇸 Los Gatos, California, United States

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center; 🇺🇸 Orange, California, United States

University of Colorado Cancer Center at University of Colorado Health Sciences Center; 🇺🇸 Denver, Colorado, United States

Yale Comprehensive Cancer Center at Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

CCOP - Christiana Care Health Services; 🇺🇸 Newark, Delaware, United States

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida; 🇺🇸 Tampa, Florida, United States

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